Venture firm Flagship Pioneering Inc. and Pfizer Inc. are each investing $50 million in a pact that could result in the development of 10 programs, each worth a potential $700 million in milestones. Altogether, if all products are successfully commercialized, the deal could be worth $7 billion, with milestone money going to Flagship and some of its 45 bioplatform companies. Read More
Strong and complete phase III results for Eli Lilly and Co.’s donanemab for treating early Alzheimer's disease (AD) will no doubt inspire more comparisons with recently approved Leqembi (lecanemab). The newly released data for donanemab show it significantly slowed cognitive and functional decline for those with amyloid-positive early symptomatic AD, which lowered the disease-progression risk. Read More
Apellis Pharmaceutical Inc.’s shares nosedived by 37% July 17 after the American Society of Retina Specialists wrote to ophthalmologists warning them of the risk of serious intraocular inflammation events in patients following injection of the company’s geographic atrophy drug, Syfovre (pegcetacoplan). Read More
On the heels of a licensing deal last week, Genequantum Healthcare Co. Ltd. has struck another deal, this time out-licensing its conjugation technology to Inxmed Co. Ltd. to support development of next-generation targeted antibody-drug conjugates (ADCs). Read More
Argenx SE’s top-line results from the phase II Adhere study with Vyvgart Hytrulo (efgartigimod alfa plus hyaluronidase-qvfc) in chronic inflammatory demyelinating polyneuropathy (CIDP) sparked buzz about other developers in the space with similar mechanisms of action to Vyvgart Hytrulo, such as Immunovant Inc. Read More
Elevar Therapeutics Inc. said that the U.S. FDA accepted its NDA for oral tyrosine kinase inhibitor rivoceranib in combination with PD-1 inhibitor camrelizumab (Airuika) as a first-line treatment for liver cancer. The FDA stamped an official PDUFA target action date of May 16, 2024. Read More
Responding to medical advances and new standards of care in Alzheimer’s, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to end its 10-year-old coverage with evidence development policy that has limited Medicare reimbursement of amyloid PET scans to once in a lifetime for beneficiaries – and then only when they’re used in a CMS-approved trial. Read More
A committee of the U.S. House of Representatives met to review the Medicare coverage procedure for innovative drugs and devices, an event that seemed to gin up support for legislation that would help to streamline those processes. The problem for drug and device makers, however, may be that the Centers for Medicare & Medicaid Services
continues to labor under a flat appropriations picture that is eroding daily thanks to inflation. Read More
The U.S. SEC is settling insider trading charges against Nirdosh Jagota, former vice president of global regulatory affairs at Merck & Co. Inc., stemming from Merck’s $1.85 billion acquisition of Pandion Therapeutics Inc. in 2021. Read More
Johnson & Johnson and its Janssen pharmaceutical companies added their name July 18 to the growing list of biopharma companies and organizations challenging the Inflation Reduction Act’s (IRA) mandated drug price negotiations. Read More
New and updated clinical data presented by biopharma firms at the Alzheimer's Association International Conference, including: Acumen, Alnylam, Athira, Biovie, Coya, Nkgen, Prothena, Taurx. Read More
Biopharmas raising money in public or private financings, including: Acelrx, Acumen, Argenx, Bicycle, Cel-Sci, Eterna, Lixte, Pharmather, Renibus, Verismo, Westlake Village, Zai. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altamira, Biolinerx, Bridgebio, Clearside, Compass, Halozyme, Highfield, Immix, Janux, Vaxxinity. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advent, Astrazeneca, Bayer, Celtic, Defence, Exscientia, FSD, Genprex, Neoleukin, Neurogene, Northstar, Novartis, Nysnobio, Orano, Pieris, Sanofi, Scribe, Simris, Syneos. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antengene, Arrowhead, Dong-A, Elevar, Madrigal. Read More
